EP 4137574 A1 20230222 - COLOR REMOVAL METHOD FOR PROTEIN FORMULATION ACTIVE INGREDIENT
Title (en)
COLOR REMOVAL METHOD FOR PROTEIN FORMULATION ACTIVE INGREDIENT
Title (de)
FARBENTFERNUNGSVERFAHREN FÜR EINEN PROTEINFORMULIERUNGSWIRKSTOFF
Title (fr)
PROCÉDÉ D'ÉLIMINATION DE COULEUR POUR PRINCIPE ACTIF DE FORMULATION DE PROTÉINE
Publication
Application
Priority
- JP 2020073753 A 20200417
- JP 2021015665 W 20210416
Abstract (en)
A problem of the present invention is to provide a method for removing coloration from a drug substance solution of protein preparation, in particular, antibody preparation, a method for preparing drug substance solution of protein preparations including it, as a part thereof, and highly concentrated, colorless drug substance solutions thereof.The present invention provides a method for removing terminal glycation products causing the coloration in the drug substance solution of protein preparation, in particular, antibody preparation, by anion-exchange chromatography. This method has made it possible to provide colorless drug substance solutions.
IPC 8 full level
C12N 15/13 (2006.01); A61K 9/08 (2006.01); A61K 39/395 (2006.01); A61P 35/00 (2006.01); A61P 35/02 (2006.01); A61P 37/06 (2006.01); C07K 1/18 (2006.01); C07K 16/28 (2006.01); C07K 16/46 (2006.01)
CPC (source: EP US)
A61K 9/08 (2013.01 - US); A61K 39/395 (2013.01 - US); A61P 35/00 (2017.12 - EP); A61P 35/02 (2017.12 - EP); A61P 37/06 (2017.12 - EP); B01D 15/168 (2013.01 - US); B01D 15/363 (2013.01 - US); B01D 15/424 (2013.01 - US); C07K 1/18 (2013.01 - EP US); C07K 16/28 (2013.01 - US); C07K 16/2809 (2013.01 - EP); C07K 16/2818 (2013.01 - EP); A61K 9/0019 (2013.01 - EP); C07K 2317/31 (2013.01 - EP US); C07K 2317/51 (2013.01 - US); C07K 2317/515 (2013.01 - US)
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
Designated validation state (EPC)
KH MA MD TN
DOCDB simple family (publication)
EP 4137574 A1 20230222; EP 4137574 A4 20240508; JP WO2021210662 A1 20211021; US 2023143066 A1 20230511; WO 2021210662 A1 20211021
DOCDB simple family (application)
EP 21788761 A 20210416; JP 2021015665 W 20210416; JP 2022515444 A 20210416; US 202117995686 A 20210416